– Defining clear, objective, and clinically relevant outcomes

◦ Prognostic: IBD–related surgery versus IBD-related hospitalisation versus new disease-related complications versus need for biologic/small-molecule agents versus IBD-DI [Disability Index] versus cumulative bowel damage scores [such as Lémann index] versus …

◦ Predictive: mucosal versus transmural healing, and definitions for these

– Incorporating adequate drug concentration for biomarkers of response to therapy

– Assessing biomarkers in specific patient populations and/or timepoints in the disease course

◦ Prognostic: at diagnosis and in postoperative setting

◦ Predictive: biologic-naïve patients versus at the time of biologic failure [considering prior/current drug exposures]

– Defining criteria for evaluating performance and impact of new biomarkers

– Standardization of baseline clinical data and phenotyping, including response, across independent studies, allowing pooled data analysis and direct comparisons

– Biomarker incorporation into clinical trials: early-phase interventional trials in IBD should have exploratory biomarker development projects built into funding, design, and analysis. Results should be published, even if negative. Appreciation for the length of time and preparation required prior to initiation of such designs, and the general difficulties of obtaining funding for pre-trial methodology and planning activities

– Increased academia-industry collaborations to combine intellectual expertise and experience and to mine randomized controlled trial datasets and samples

– Well-powered ambitious prospective studies that are specifically designed towards accumulation of data for several molecular layers